Mild to Moderate Anxiety and DepressionNCT06978257
Digital Positive Affect Intervention Study
A study testing Digital positive affect intervention (PAI) and Self-monitoring intervention in people with Mild to Moderate Anxiety and Depression, run by National University of Singapore at 1 site in Singapore.
Trial summary
Anxiety and depression are highly prevalent mental health disorders that impose a significant burden on individuals and public health systems worldwide (GBD 2019 Mental Disorders Collaborators, 2022). Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Mild to Moderate Anxiety and Depression
- What is being tested?
- Digital positive affect intervention (PAI) and Self-monitoring intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Apr 2025to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged between 21 and 64 years
- Proficient in written and spoken English
- Ability to provide informed consent
- Scores between 5 and 14 on the Generalized Anxiety Disorder-7 (GAD-7) scale OR
- Scores between 5 and 19 on the Patient Health Questionnaire-9 (PHQ-9) scale
- Scores below 6 on the Altman Self-Rating Mania (ASRM) scale
Show all 13Show fewer
- Possess an active smartphone with a valid Singapore phone number
- Mainly based in Singapore, within the next 15 months Exclusion criteria
- Failure to meet the above inclusion criteria
- Significant suicidal thoughts within the past two weeks, defined as self-reporting "more than half the days" or "nearly every day" on the PHQ-9 Item 9.
- Received psychiatric diagnoses of bipolar disorder, disorders of psychosis, severe clinical anxiety, or severe clinical depression.
- Severe clinical anxiety (scores of 15 to 21 on the GAD-7)
- Severe clinical depression (scores of 20-27 on the PHQ-9)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National University of Singapore (NUS)
Singapore, 117571
Nur Hani Zainal, Ph.D., +6565161126, hanizainal@nus.edu.sg
Sarah Josephine Rajendra, B.S., +6565161126, sarah.jr@nus.edu.sg
About this study
Official title: Protocol of a Two-Arm Randomized Controlled Trial (RCT) of Digital Positive Affect Intervention Study
Anxiety and depression are highly prevalent mental health disorders that impose a significant burden on individuals and public health systems worldwide (GBD 2019 Mental Disorders Collaborators, 2022). Although many existing treatments focus on symptom reduction through targeting negative emotions, fewer interventions specifically enhance positive emotional experiences, despite growing evidence that low positive affect is a key feature of both anxiety and depression. Face-to-face psychologist-led positive affect therapy (PAT) is a promising intervention that aims to cultivate positive emotions, engagement, and meaning, potentially leading to greater improvements in emotional well-being than traditional approaches (Craske et al., 2019). However, empirical evaluations of digitally-delivered, asynchronously-coached, scalable versions of the PAT remain limited (Craske et al., 2024; Firth et al., 2017). The present study thus aims to investigate the comparative efficacy of a digital positive affect intervention (PAI) in reducing symptoms of anxiety and depression and enhancing overall mental health outcomes. We utilize a two-arm randomized controlled trial (RCT) design to investigate the effectiveness of a six-week digitally delivered positive affect intervention (vs. self-monitoring active control; Zainal \& Newman, 2023) in reducing self-reported symptoms of anxiety and depression, as well as other secondary psychosocial outcomes, including sleep quality, quality of life, and emotion regulation. The treatment program comprises weekly evidence-based therapeutic material delivered online, and daily mental health (MH) mobile application prompts delivered thrice a day for the 6-week treatment period, based on evidence-based positive affect therapy principles. The active comparator comprises self-monitoring MH mobile application prompts for the 6-week treatment period. All participants will be assessed on several psychosocial outcomes at mid-treatment, post-treatment, and at 3-, 6-, and 12-month follow-up. The study hypothesizes that participants randomized to the digital PAI will experience greater improvement in anxious and depressive symptoms both immediately after treatment and up to a year later, compared to the self-monitoring MH app. Findings will contribute to growing evidence that digital PAI is an efficacious and feasible treatment to target and enhance positive emotions and related mental health outcomes in adults experiencing anxiety and depression.
Read the detailed description
The present two-arm randomized controlled trial rigorously evaluates the efficacy of a six-week digitally-delivered positive affect intervention (PAI) compared to a self-monitoring active control among adults reporting symptoms of anxiety or depression. Participants (N=2400), recruited from the National University of Singapore and the broader community, are randomized to one of two arms: (1) the PAI, which provides weekly evidence-based therapeutic content via Qualtrics alongside daily ecological momentary prompts via mEMA Ilumivu platform to cultivate positive affect, or (2) an active control that engages participants in mood self-monitoring through a mental health mobile application. The intervention is designed to target positive emotion enhancement as a core mechanism for improving emotional well-being, reducing anxious and depressive symptoms, and bolstering resilience factors. Assessments are administered at baseline, mid-intervention (Week 3), post-intervention (Week 6), and follow-ups at 3, 6, and 12 months, capturing a comprehensive suite of psychosocial outcomes including quality of life, sleep quality, and emotion regulation capacities.
The study further investigates mediators and moderators to elucidate how and for whom the intervention confers benefit, providing granular insight into mechanisms of change. Subjects in the PAI arm also complete post-treatment assessments of satisfaction and cultural relevance to assess acceptability and contextual fit, an important consideration for digital mental health interventions (DMHIs). Both arms receive regular ecological momentary assessments three times daily to reinforce engagement and capture in-the-moment affective experiences. With its fully digital, scalable design, the trial not only tests clinical effectiveness but also addresses feasibility and user engagement, contributing meaningfully to the growing literature on positive emotion-focused digital interventions and their potential for integration into stepped-care mental health frameworks. This work is poised to advance understanding of digital therapeutic strategies that extend beyond symptom reduction to actively build psychological resilience and flourishing.
- Conditions
- Mild to Moderate Anxiety and Depression
- Being tested
- Digital positive affect intervention (PAI), Self-monitoring intervention
- Keywords
- anxiety, depression
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital positive affect intervention (PAI)Behavioural
The Positive Affect Intervention (PAI) is a fully digital, self-guided program uniquely designed to deliver weekly 30-minute online sessions focused on cultivating positive emotions, meaning, and engagement, alongside daily ecological momentary prompts delivered thrice daily over six weeks. Distinctively, the intervention seamlessly integrates multimedia content (e.g., brief weekly videos introducing each session's core principles), practical exercises, and in-the-moment reflection, aiming to reinforce positive affect skills in real time. Its structure not only emphasizes proactive skill application through digital reminders but also systematically assesses user engagement and perceived helpfulness via ecological momentary assessments and post-session feedback questionnaires.
Unlike conventional digital interventions that primarily focus on symptom reduction through passive content consumption, this PAI leverages continuous ecological momentary engagement via a dedicated mobile app, e
Self-monitoring interventionBehavioural
The self-monitoring intervention serves as an active comparator designed to isolate the effects of mood self-awareness without introducing therapeutic content. Participants in this arm receive daily prompts via the Qualtrics mEMA mobile app, three times per day over a six-week period, instructing them to track their mood and emotional states through brief ecological momentary assessments (EMAs). Unlike the digital positive affect intervention, this arm does not include psychoeducational material, skills training, or active enhancement strategies; instead, it focuses solely on routine self-monitoring to control for digital engagement and expectancy effects. This minimalist structure allows for a clean contrast between passive self-observation and active therapeutic engagement, enabling robust evaluation of the added value of the Positive Affect Intervention beyond self-monitoring alone
| Study group | Role | What they receive |
|---|---|---|
| Digital positive affect intervention (PAI) | Experimental | Access to weekly evidence-based positive affect intervention delivered online via Qualtrics surveys, and access to thrice daily evidence-based prompts and ecological momentary assessments (EMAs) delivered via a mental health (MH) mobile application for the 6-week treatment period. Receives: Behavioral: Digital positive affect intervention (PAI) |
| Self-monitoring intervention | Active comparator | Access to thrice-daily self-monitoring prompts and ecological momentary assessments (EMAs) delivered via a mental health (MH) mobile application for the 6-week treatment period. Receives: Behavioral: Self-monitoring intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Generalized Anxiety Disorder Symptoms at 6 weeks post-randomization
Generalized Anxiety Disorder-7 (GAD-7) scale contains 8 items measuring the frequency and intensity of anxiety symptoms, rated on a scale of 0-3 (0 = not at all, 3 = nearly every day). Higher scores reflect a greater reduction in anxiety symptoms.
Measured: Baseline to 6 weeks post-randomization
Change from baseline Generalized Anxiety Disorder symptoms at 3, 6, and 12 months post-randomization
Generalized Anxiety Disorder-7 (GAD-7) scale contains 8 items measuring the frequency and intensity of anxiety symptoms, rated on a scale of 0-3 (0 = not at all, 3 = nearly every day). Higher scores reflect a greater reduction in anxiety symptoms.
Measured: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline depressive symptoms at 6 weeks post-randomization
Patient Health Questionnaire-9 (PHQ-9) measures the severity and frequency of depressive symptoms with nine items rated on a scale of 0 to 3 (0 = not at all, 3 = nearly every day). Higher scores indicate a greater reduction in depressive symptoms.
Measured: Baseline to 6 weeks post-randomization
Change from baseline depressive symptoms at 3, 6, and 12 months post-randomization
Patient Health Questionnaire-9 (PHQ-9) measures the severity and frequency of depressive symptoms with nine items rated on a scale of 0 to 3 (0 = not at all, 3 = nearly every day). Higher scores indicate a greater reduction in depressive symptoms.
Measured: Baseline to 3 months, 6 months, and 12 months post-randomization
Secondary outcomes (22)
Change from baseline emotion regulation strategies at 6 weeks post-randomization
The Emotion Regulation Questionnaire (ERQ) measures individuals' tendencies to regulate their emotions through cognitive reappraisal and expressive suppression. 10 items are rated on a scale of 1 to 7 (1 = strongly disagree, 7 = strongly agree). Higher scores indicate higher tendency to use that particular emotion regulation strategy.
Measured: Baseline to 6 weeks post-randomization
Change from baseline emotion regulation strategies at 3, 6, and 12 months post-randomization
The Emotion Regulation Questionnaire (ERQ) measures individuals' tendencies to regulate their emotions through cognitive reappraisal and expressive suppression. 10 items are rated on a scale of 1 to 7 (1 = strongly disagree, 7 = strongly agree). Higher scores indicate higher tendency to use that particular emotion regulation strategy.
Measured: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline automatic thoughts at 6 weeks post-randomization
The Automatic Thoughts Questionnaire (ATQ) assesses the frequency of negative automatic thoughts associated with depression. Eight items are rated on a scale of 1 to 5 (1 = not at all, 5 = all the time). Higher scores indicate greater reductions in the frequency of negative thoughts.
Measured: Baseline to 6 weeks post-randomization
Change from baseline automatic thoughts at 3, 6, and 12 months post-randomization
The Automatic Thoughts Questionnaire (ATQ) assesses the frequency of negative automatic thoughts associated with depression. Eight items are rated on a scale of 1 to 5 (1 = not at all, 5 = all the time). Higher scores indicate greater reductions in the frequency of negative thoughts.
Measured: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline attentional control at 6 weeks post-randomization
The Attentional Control Scale (ACS) assesses individuals' ability to focus and shift attention in the presence of distractions. 20 items are rated on a scale of 1 to 4 (1 = almost never, 4 = always). Higher scores indicate greater reductions in problems with regulating attention efficiently.
Measured: Baseline to 6 weeks post-randomization
Change from baseline attentional control at 3, 6, and 12 months post-randomization
The Attentional Control Scale (ACS) assesses individuals' ability to focus and shift attention in the presence of distractions. 20 items are rated on a scale of 1 to 4 (1 = almost never, 4 = always). Higher scores indicate greater reductions in problems with regulating attention efficiently.
Measured: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline self-compassion at 6 weeks post-randomization
The Self-Compassion Scale - Short Form (SCS-SF) assesses the frequency of self-compassionate behaviors and provides an evaluation of how individuals treat themselves during difficult times. 12 items are rated on a scale of 1 to 5 (1 = almost never, 5 = almost always). Higher scores indicate greater increases in self-compassion.
Measured: Baseline to 6 weeks post-randomization
Change from baseline self-compassion at 3, 6, and 12 months post-randomization
The Self-Compassion Scale - Short Form (SCS-SF) assesses the frequency of self-compassionate behaviors and provides an evaluation of how individuals treat themselves during difficult times. 12 items are rated on a scale of 1 to 5 (1 = almost never, 5 = almost always). Higher scores indicate greater increases in self-compassion.
Measured: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline mental well-being at 6 weeks post-randomization
The Mental Health Continuum - Short Form (MHC-SF) assesses overall mental well-being across emotional, psychological, and social dimensions. 17 items are rated on a scale of 0 to 5 (0 = never, 5 = every day). Higher scores indicate greater increases in flourishing.
Measured: Baseline to 6 weeks post-randomization
Change from baseline mental well-being at 3, 6, and 12 months post-randomization
The Mental Health Continuum - Short Form (MHC-SF) assesses overall mental well-being across emotional, psychological, and social dimensions. 17 items are rated on a scale of 0 to 5 (0 = never, 5 = every day). Higher scores indicate flourishing.
Measured: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline positive affect at 6 weeks post-randomization
The Positive and Negative Affect Schedule (PANAS) - PA subscale measures the extent to which an individual experiences positive emotion. 10 items are rated on a scale of 1 to 5 (1 = very slightly or not at all, 5 = extremely). Higher scores indicate greater increases in positive affect.
Measured: Baseline to 6 weeks post-randomization
Change from baseline positive affect at 3, 6, and 12 months post-randomization
The Positive and Negative Affect Schedule (PANAS) - PA subscale measures the extent to which an individual experiences positive emotion. 10 items are rated on a scale of 1 to 5 (1 = very slightly or not at all, 5 = extremely). Higher scores indicate greater increases in positive affect.
Measured: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline negative affect at 6 weeks post-randomization
The Positive and Negative Affect Schedule (PANAS) - NA subscale measures the extent to which an individual experiences positive emotion. 10 items are rated on a scale of 1 to 5 (1 = very slightly or not at all, 5 = extremely). Higher scores indicate greater increases in negative affect.
Measured: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline negative affect at 3, 6, and 12 months post-randomization
The Positive and Negative Affect Schedule (PANAS) - NA subscale measures the extent to which an individual experiences positive emotion. 10 items are rated on a scale of 1 to 5 (1 = very slightly or not at all, 5 = extremely). Higher scores indicate greater increases in negative affect.
Measured: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline anhedonia at 6 weeks post-randomization
The Dimensional Anhedonia Rating Scale (DARS) measures anhedonia by assessing desire, motivation, effort, and consummatory pleasure across four domains: hobbies, food/drink, social activities, and sensory experiences.17 items are rated on a 5-point scale of not at all to very much. Higher scores indicate greater reductions in anhedonia.
Measured: Baseline to 6 weeks post-randomization
Change from baseline anhedonia at 3, 6, and 12 months post-randomization
The Dimensional Anhedonia Rating Scale (DARS) measures anhedonia by assessing desire, motivation, effort, and consummatory pleasure across four domains: hobbies, food/drink, social activities, and sensory experiences.17 items are rated on a 5-point scale of not at all to very much. Higher scores indicate greater reductions in anhedonia.
Measured: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline positive valence at 6 weeks post-randomization
The Positive Valence Systems Scale (PVSS) assesses the positive valence system on several dimensions of rewards, food, physical touch and social interactions. Twenty-one items are rated on a scale of 1 to 9 (1 = extremely untrue of me, 9 = extremely true of me). Higher scores indicate stronger or more frequent responsiveness to a wide range of rewarding experiences.
Measured: Baseline to 6 weeks post-randomization
Change from baseline positive valence systems at 3, 6, and 12 months post-randomization
The Positive Valence Systems Scale (PVSS) assesses the positive valence system on several dimensions of rewards, food, physical touch and social interactions. 21 items are rated on a scale of 1 to 9 (1 = extremely untrue of me, 9 = extremely true of me). Higher scores indicate stronger or more frequent responsiveness to a wide range of rewarding experiences.
Measured: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline perceived stress at 6 weeks post-randomization
The Perceived Stress Scale (PSS) measures the degree to which individuals appraise situations in their lives as stressful, unpredictable, and uncontrollable. 10 items are rated on a scale of 0 to 4 (0 = never, 4 = very often). Higher scores indicate greater reductions in levels of perceived stress.
Measured: Baseline to 6 weeks post-randomization
Change from baseline perceived stress at 3, 6, and 12 months post-randomization
The Perceived Stress Scale (PSS) measures the degree to which individuals appraise situations in their lives as stressful, unpredictable, and uncontrollable. 10 items are rated on a scale of 0 to 4 (0 = never, 4 = very often). Higher scores indicate greater reductions in levels of perceived stress.
Measured: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline sleep quality at 6 weeks post-randomization
The Pittsburgh Sleep Quality Indicator (PSQI) assesses quality of sleep over a one-month period. The PSQI consists of 19 items that generate scores for seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. These components are summed to yield a global score ranging from 0 to 21. Higher scores indicate greater reductions in poor sleep quality.
Measured: Baseline to 6 weeks post-randomization
Change from baseline sleep quality at 3, 6, and 12 months post-randomization
The Pittsburgh Sleep Quality Indicator (PSQI) assesses quality of sleep over a one-month period. The PSQI consists of 19 items that generate scores for seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. These components are summed to yield a global score ranging from 0 to 21. Higher scores indicate greater reductions in poor sleep quality.
Measured: Baseline to 3 months, 6 months, and 12 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Apr 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate Anxiety and DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Hani Zainal, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978257
- Sponsor's protocol ID
- NUS-IRB-2024-877
- Status last verified
- Jun 2025
- First submitted
- 10 May 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At present, we are undecided about sharing individual participant data (IPD) because data governance, privacy considerations, and long-term storage protocols are still under review to ensure full compliance with institutional and regulatory guidelines. While we recognize the importance of data sharing for advancing scientific transparency and collaboration, any future decision to share IPD will be contingent on securing appropriate ethical approvals, ensuring participant confidentiality, and establishing secure data-sharing agreements that meet stringent data protection standards.
Publications
Zainal NH, Newman MG. A randomized controlled trial of a 14-day mindfulness ecological momentary intervention (MEMI) for generalized anxiety disorder. Eur Psychiatry. 2023 Jan 16;66(1):e12. doi: 10.1192/j.eurpsy.2023.2.
PubMed 36645098Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Rizvi SJ, Quilty LC, Sproule BA, Cyriac A, Michael Bagby R, Kennedy SH. Development and validation of the Dimensional Anhedonia Rating Scale (DARS) in a community sample and individuals with major depression. Psychiatry Res. 2015 Sep 30;229(1-2):109-19. doi: 10.1016/j.psychres.2015.07.062. Epub 2015 Jul 26.
PubMed 26250147Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
PubMed 21584907Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Khazanov GK, Xu C, Dunn BD, Cohen ZD, DeRubeis RJ, Hollon SD. Distress and anhedonia as predictors of depression treatment outcome: A secondary analysis of a randomized clinical trial. Behav Res Ther. 2020 Feb;125:103507. doi: 10.1016/j.brat.2019.103507. Epub 2019 Oct 31.
PubMed 31896529Keyes CL. The mental health continuum: from languishing to flourishing in life. J Health Soc Behav. 2002 Jun;43(2):207-22.
PubMed 12096700Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.
PubMed 12916575GBD 2019 Mental Disorders Collaborators. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022 Feb;9(2):137-150. doi: 10.1016/S2215-0366(21)00395-3. Epub 2022 Jan 10.
PubMed 35026139Firth J, Torous J, Nicholas J, Carney R, Pratap A, Rosenbaum S, Sarris J. The efficacy of smartphone-based mental health interventions for depressive symptoms: a meta-analysis of randomized controlled trials. World Psychiatry. 2017 Oct;16(3):287-298. doi: 10.1002/wps.20472.
PubMed 28941113Derryberry D, Reed MA. Anxiety-related attentional biases and their regulation by attentional control. J Abnorm Psychol. 2002 May;111(2):225-36. doi: 10.1037//0021-843x.111.2.225.
PubMed 12003445Craske MG, Meuret AE, Ritz T, Treanor M, Dour H, Rosenfield D. Positive affect treatment for depression and anxiety: A randomized clinical trial for a core feature of anhedonia. J Consult Clin Psychol. 2019 May;87(5):457-471. doi: 10.1037/ccp0000396.
PubMed 30998048Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol of a Two-Arm Randomized Controlled Trial (RCT) of Digital Positive Affect Intervention Study
- ClinicalTrials.gov ID
- NCT06978257
- Acronym / sponsor ID
- NUS-IRB-2024-877
- Conditions
- Mild to Moderate Anxiety and Depression
- Keywords
- anxiety, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anxiety and depression are highly prevalent mental health disorders that impose a significant burden on individuals and public health systems worldwide (GBD 2019 Mental Disorders Collaborators, 2022). Although many existing treatments focus on symptom reduction through targeting negative emotions, fewer interventions specifically enhance positive emotional experiences, despite growing evidence that low positive affect is a key feature of both anxiety and depression. Face-to-face psychologist-led positive affect therapy (PAT) is a promising intervention that aims to cultivate positive emotions, engagement, and meaning, potentially leading to greater improvements in emotional well-being than traditional approaches (Craske et al., 2019). However, empirical evaluations of digitally-delivered, asynchronously-coached, scalable versions of the PAT remain limited (Craske et al., 2024; Firth et al., 2017). The present study thus aims to investigate the comparative efficacy of a digital positive affect intervention (PAI) in reducing symptoms of anxiety and depression and enhancing overall mental health outcomes. We utilize a two-arm randomized controlled trial (RCT) design to investigate the effectiveness of a six-week digitally delivered positive affect intervention (vs. self-monitoring active control; Zainal \& Newman, 2023) in reducing self-reported symptoms of anxiety and depression, as well as other secondary psychosocial outcomes, including sleep quality, quality of life, and emotion regulation. The treatment program comprises weekly evidence-based therapeutic material delivered online, and daily mental health (MH) mobile application prompts delivered thrice a day for the 6-week treatment period, based on evidence-based positive affect therapy principles. The active comparator comprises self-monitoring MH mobile application prompts for the 6-week treatment period. All participants will be assessed on several psychosocial outcomes at mid-treatment, post-treatment, and at 3-, 6-, and 12-month follow-up. The study hypothesizes that participants randomized to the digital PAI will experience greater improvement in anxious and depressive symptoms both immediately after treatment and up to a year later, compared to the self-monitoring MH app. Findings will contribute to growing evidence that digital PAI is an efficacious and feasible treatment to target and enhance positive emotions and related mental health outcomes in adults experiencing anxiety and depression.
Detailed description
The present two-arm randomized controlled trial rigorously evaluates the efficacy of a six-week digitally-delivered positive affect intervention (PAI) compared to a self-monitoring active control among adults reporting symptoms of anxiety or depression. Participants (N=2400), recruited from the National University of Singapore and the broader community, are randomized to one of two arms: (1) the PAI, which provides weekly evidence-based therapeutic content via Qualtrics alongside daily ecological momentary prompts via mEMA Ilumivu platform to cultivate positive affect, or (2) an active control that engages participants in mood self-monitoring through a mental health mobile application. The intervention is designed to target positive emotion enhancement as a core mechanism for improving emotional well-being, reducing anxious and depressive symptoms, and bolstering resilience factors. Assessments are administered at baseline, mid-intervention (Week 3), post-intervention (Week 6), and follow-ups at 3, 6, and 12 months, capturing a comprehensive suite of psychosocial outcomes including quality of life, sleep quality, and emotion regulation capacities.
The study further investigates mediators and moderators to elucidate how and for whom the intervention confers benefit, providing granular insight into mechanisms of change. Subjects in the PAI arm also complete post-treatment assessments of satisfaction and cultural relevance to assess acceptability and contextual fit, an important consideration for digital mental health interventions (DMHIs). Both arms receive regular ecological momentary assessments three times daily to reinforce engagement and capture in-the-moment affective experiences. With its fully digital, scalable design, the trial not only tests clinical effectiveness but also addresses feasibility and user engagement, contributing meaningfully to the growing literature on positive emotion-focused digital interventions and their potential for integration into stepped-care mental health frameworks. This work is poised to advance understanding of digital therapeutic strategies that extend beyond symptom reduction to actively build psychological resilience and flourishing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital positive affect intervention (PAI) | Experimental | Behavioral: Digital positive affect intervention (PAI)Access to weekly evidence-based positive affect intervention delivered online via Qualtrics surveys, and access to thrice daily evidence-based prompts and ecological momentary assessments (EMAs) delivered via a mental health (MH) mobile application for the 6-week treatment period. |
| Self-monitoring intervention | Active comparator | Behavioral: Self-monitoring interventionAccess to thrice-daily self-monitoring prompts and ecological momentary assessments (EMAs) delivered via a mental health (MH) mobile application for the 6-week treatment period. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Adults aged between 21 and 64 years
- Proficient in written and spoken English
- Ability to provide informed consent
- Scores between 5 and 14 on the Generalized Anxiety Disorder-7 (GAD-7) scale OR
- Scores between 5 and 19 on the Patient Health Questionnaire-9 (PHQ-9) scale
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital positive affect intervention (PAI)The Positive Affect Intervention (PAI) is a fully digital, self-guided program uniquely designed to deliver weekly 30-minute online sessions focused on cultivating positive emotions, meaning, and engagement, alongside daily ecological momentary prompts delivered thrice daily over six weeks. Distinctively, the intervention seamlessly integrates multimedia content (e.g., brief weekly videos introducing each session's core principles), practical exercises, and in-the-moment reflection, aiming to reinforce positive affect skills in real time. Its structure not only emphasizes proactive skill application through digital reminders but also systematically assesses user engagement and perceived helpfulness via ecological momentary assessments and post-session feedback questionnaires. Unlike conventional digital interventions that primarily focus on symptom reduction through passive content consumption, this PAI leverages continuous ecological momentary engagement via a dedicated mobile app, e | Behavioural | Digital positive affect intervention (PAI) |
| Self-monitoring interventionThe self-monitoring intervention serves as an active comparator designed to isolate the effects of mood self-awareness without introducing therapeutic content. Participants in this arm receive daily prompts via the Qualtrics mEMA mobile app, three times per day over a six-week period, instructing them to track their mood and emotional states through brief ecological momentary assessments (EMAs). Unlike the digital positive affect intervention, this arm does not include psychoeducational material, skills training, or active enhancement strategies; instead, it focuses solely on routine self-monitoring to control for digital engagement and expectancy effects. This minimalist structure allows for a clean contrast between passive self-observation and active therapeutic engagement, enabling robust evaluation of the added value of the Positive Affect Intervention beyond self-monitoring alone | Behavioural | Self-monitoring intervention |
Primary outcome
Change from baseline Generalized Anxiety Disorder Symptoms at 6 weeks post-randomization
Time frame: Baseline to 6 weeks post-randomization
Generalized Anxiety Disorder-7 (GAD-7) scale contains 8 items measuring the frequency and intensity of anxiety symptoms, rated on a scale of 0-3 (0 = not at all, 3 = nearly every day). Higher scores reflect a greater reduction in anxiety symptoms.
Change from baseline Generalized Anxiety Disorder symptoms at 3, 6, and 12 months post-randomization
Time frame: Baseline to 3 months, 6 months, and 12 months post-randomization
Generalized Anxiety Disorder-7 (GAD-7) scale contains 8 items measuring the frequency and intensity of anxiety symptoms, rated on a scale of 0-3 (0 = not at all, 3 = nearly every day). Higher scores reflect a greater reduction in anxiety symptoms.
Change from baseline depressive symptoms at 6 weeks post-randomization
Time frame: Baseline to 6 weeks post-randomization
Patient Health Questionnaire-9 (PHQ-9) measures the severity and frequency of depressive symptoms with nine items rated on a scale of 0 to 3 (0 = not at all, 3 = nearly every day). Higher scores indicate a greater reduction in depressive symptoms.
Change from baseline depressive symptoms at 3, 6, and 12 months post-randomization
Time frame: Baseline to 3 months, 6 months, and 12 months post-randomization
Patient Health Questionnaire-9 (PHQ-9) measures the severity and frequency of depressive symptoms with nine items rated on a scale of 0 to 3 (0 = not at all, 3 = nearly every day). Higher scores indicate a greater reduction in depressive symptoms.
22 secondary outcomes
Change from baseline emotion regulation strategies at 6 weeks post-randomization
Time frame: Baseline to 6 weeks post-randomization
Change from baseline emotion regulation strategies at 3, 6, and 12 months post-randomization
Time frame: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline automatic thoughts at 6 weeks post-randomization
Time frame: Baseline to 6 weeks post-randomization
Change from baseline automatic thoughts at 3, 6, and 12 months post-randomization
Time frame: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline attentional control at 6 weeks post-randomization
Time frame: Baseline to 6 weeks post-randomization
Change from baseline attentional control at 3, 6, and 12 months post-randomization
Time frame: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline self-compassion at 6 weeks post-randomization
Time frame: Baseline to 6 weeks post-randomization
Change from baseline self-compassion at 3, 6, and 12 months post-randomization
Time frame: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline mental well-being at 6 weeks post-randomization
Time frame: Baseline to 6 weeks post-randomization
Change from baseline mental well-being at 3, 6, and 12 months post-randomization
Time frame: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline positive affect at 6 weeks post-randomization
Time frame: Baseline to 6 weeks post-randomization
Change from baseline positive affect at 3, 6, and 12 months post-randomization
Time frame: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline negative affect at 6 weeks post-randomization
Time frame: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline negative affect at 3, 6, and 12 months post-randomization
Time frame: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline anhedonia at 6 weeks post-randomization
Time frame: Baseline to 6 weeks post-randomization
Change from baseline anhedonia at 3, 6, and 12 months post-randomization
Time frame: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline positive valence at 6 weeks post-randomization
Time frame: Baseline to 6 weeks post-randomization
Change from baseline positive valence systems at 3, 6, and 12 months post-randomization
Time frame: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline perceived stress at 6 weeks post-randomization
Time frame: Baseline to 6 weeks post-randomization
Change from baseline perceived stress at 3, 6, and 12 months post-randomization
Time frame: Baseline to 3 months, 6 months, and 12 months post-randomization
Change from baseline sleep quality at 6 weeks post-randomization
Time frame: Baseline to 6 weeks post-randomization
Change from baseline sleep quality at 3, 6, and 12 months post-randomization
Time frame: Baseline to 3 months, 6 months, and 12 months post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Results publication: PubMed 36645098Zainal NH, Newman MG. A randomized controlled trial of a 14-day mindfulness ecological momentary intervention (MEMI) for generalized anxiety disorder. Eur Psychiatry. 2023 Jan 16;66(1):e12. doi: 10.1192/j.eurpsy.2023.2.
- Results publication: PubMed 3397865Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Results publication: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Results publication: PubMed 26250147Rizvi SJ, Quilty LC, Sproule BA, Cyriac A, Michael Bagby R, Kennedy SH. Development and validation of the Dimensional Anhedonia Rating Scale (DARS) in a community sample and individuals with major depression. Psychiatry Res. 2015 Sep 30;229(1-2):109-19. doi: 10.1016/j.psychres.2015.07.062. Epub 2015 Jul 26.
- Results publication: PubMed 21584907Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
- Results publication: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Results publication: PubMed 31896529Khazanov GK, Xu C, Dunn BD, Cohen ZD, DeRubeis RJ, Hollon SD. Distress and anhedonia as predictors of depression treatment outcome: A secondary analysis of a randomized clinical trial. Behav Res Ther. 2020 Feb;125:103507. doi: 10.1016/j.brat.2019.103507. Epub 2019 Oct 31.
- Results publication: PubMed 12096700Keyes CL. The mental health continuum: from languishing to flourishing in life. J Health Soc Behav. 2002 Jun;43(2):207-22.
- Results publication: PubMed 12916575Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.
- Results publication: PubMed 35026139GBD 2019 Mental Disorders Collaborators. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022 Feb;9(2):137-150. doi: 10.1016/S2215-0366(21)00395-3. Epub 2022 Jan 10.
- Results publication: PubMed 28941113Firth J, Torous J, Nicholas J, Carney R, Pratap A, Rosenbaum S, Sarris J. The efficacy of smartphone-based mental health interventions for depressive symptoms: a meta-analysis of randomized controlled trials. World Psychiatry. 2017 Oct;16(3):287-298. doi: 10.1002/wps.20472.
- Results publication: PubMed 12003445Derryberry D, Reed MA. Anxiety-related attentional biases and their regulation by attentional control. J Abnorm Psychol. 2002 May;111(2):225-36. doi: 10.1037//0021-843x.111.2.225.
- Craske, M. G., Dunn, B. D., Meuret, A. E., Rizvi, S. J., \& Taylor, C. T. (2024). Positive affect and reward processing in the treatment of depression, anxiety and trauma. Nature Reviews Psychology, 3(10), 665-685. https://doi.org/10.1038/s44159-024-00355Link provided by the sponsor.
- Hollon, S. D., \& Kendall, P. C. (1980). Cognitive self-statements in depression: development of an automatic thoughts questionnaire. Cognitive Therapy and Research, 4, 383-395. https://doi.org/10.1007/bf01178214Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. At present, we are undecided about sharing individual participant data (IPD) because data governance, privacy considerations, and long-term storage protocols are still under review to ensure full compliance with institutional and regulatory guidelines. While we recognize the importance of data sharing for advancing scientific transparency and collaboration, any future decision to share IPD will be contingent on securing appropriate ethical approvals, ensuring participant confidentiality, and establishing secure data-sharing agreements that meet stringent data protection standards.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital positive affect intervention (PAI) and Self-monitoring intervention in people with Mild to Moderate Anxiety and Depression, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nur Hani Zainal, Ph.D., M.A. (+6565161126, hanizainal@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Generalized Anxiety Disorder Symptoms at 6 weeks post-randomization (time frame: Baseline to 6 weeks post-randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06978257, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.